Senior QC Analyst

Redwood City, CA, USA
Dec 07, 2018
Quality, Quality Control
Required Education
Bachelors Degree
Position Type
Full time
As a member of the Bulletproof family, you'll enjoy a culture that values diversity in all things - people, work, experience levels, and much more. We tackle the toughest challenges, produce impactful results, and build solid client relationships along the way - with energy, passion, and fun. If this sounds like a good fit for you, please consider this exciting opportunity with our firm!

Manage method transfer process effectively to deliver analytical methods from one site to another. Coordinate validation and testing activities for release, stability and in-process methods to support the manufacture of product suitable for FDA and other regulatory agency licensure. The position reports to Director of Quality Control.

Principle Responsibilities and Duties:
• Manage method transfers and validation activities between Analytical Labs and Contract Testing Laboratories ( CTLs), Contract Manufacturing Operations Laboratories. Recommend revalidation or new methods when appropriate
• Review assay validation protocols, data, and reports.
• Support stability report writing.
• Prepare and/or assist in writing regulatory submissions ( IND, BLA, MAA)
• Provide creative/innovative solutions to increase operational efficiency and contribute to the on-going business process improvements
• Review data for Certificate of Analysis.
• Ensure validated state of methods and periodically review their performance. Document the overall review of methods and address gaps. Proposes requalification or revalidation of methods
• Lead or participate in Quality and Compliance initiatives.
• Ensure the maintenance of compliant QC systems including documentation with CTLs and CMOs.
Experience, Education, Training, Traits:
• Bachelor degree in Sciences, or comparable experience, and more than 3 years of progressive responsibility in a GMP environment
• Experience in a variety of analytical techniques including HPLC, electrophoresis, and spectroscopy to determine the purity and impurity profiles of proteins
• Hands-on experience with method development, validation and transfer in support of pharmaceutical manufacturing
• Exceptional attention to detail
• Exercise sound and independent judgment
• Strong project management, collaboration and organization skills
• Excellent written and oral communications skills
• Listening, interpreting and summarizing information with clear and concise verbal communication